VIVIX-M— 510(k) K241113
Substantially EquivalentVieworks Co., Ltd.
FDA 510(k) clearance K241113 for VIVIX-M, Substantially Equivalent on 2025-01-16. Applicant: Vieworks Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Vieworks Co., Ltd.
- Product code
- Code MUE
- Device class
- Class 2
- Regulation
- 21 CFR 892.1715
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anyang-Si, KR
Recent devices under product code MUE
view allMore clearances from Vieworks Co., Ltd.
view allAdverse events under product code MUE
product code MUE- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.